agency
EP Chapter 2.6.30
Quality Segment
feature
ready-to-use
packaging
pkg of 2 vials
manufacturer/tradename
PyroMAT®
application(s)
pharmaceutical
pyrogen testing
compatibility
configured for PyroMAT® System
shipped in
dry ice
suitability
pyrogenic bacteria
General description
The PYROMAT® system is a robust, easy-to-perform and ready-to-use solution for pyrogen testing, using the Monocyte Activation Test (MAT). The PYROMAT® cells are cryopreserved human monocytic cells from the Mono-Mac-6 cell line. They have been validated to be used for MAT.
The PyroMAT® System is based on the Mono-Mac-6 (MM6) cell line and uses Interleukin-6 (IL-6) as a read out.
PyroMATcells contains the crypreserved MonoMac 6 cells, 2 x 1 mL
PyroMATcells contains the crypreserved MonoMac 6 cells, 2 x 1 mL
Application
PYROMAT® cells is used to determine the pyrogenic activity in a solution or suspension by inducing interleukin production in cell cultures with human monocytes. It is used to ensure the safety of parenteral pharmaceutical products and medical devices.
Features and Benefits
- Cryopreserved ready-to-use monocytic cells
- The only cell line validated and available for the Monocyte Activation Test
- Expression of all the Toll-like Receptors responsible for pyrogen detection
Packaging
1 box of 2 vials, sufficient for 1 test
Other Notes
2 vials of cryopreserved Mono-Mac-6 cells
Download the PyroMAT® Method Software from here.
To be used with PyroMAT kit (PYR0MATKIT), Reference standard endotoxin (144.161.0001), NEP controls (MATHKSA, MATFLAGELLIN)
Legal Information
PYROMAT is a registered trademark of Merck KGaA, Darmstadt, Germany
Disclaimer
Due to the sensitivity of the product adding a temperature data logger is required. Please make sure to add one DATAL0GGER95 per every 18 packages of PyroMAT® cells.
signalword
Warning
hcodes
Hazard Classifications
Skin Sens. 1
存储类别
10 - Combustible liquids
wgk
WGK 1
flash_point_f
Not applicable
flash_point_c
Not applicable